Statement of Work.docx

Western Colorado Health Care System (WCHCS) Statement of Work (SOW)

1. Purpose The Western Colorado Health Care System (WCHCS) medical center, located on 2121 North Ave, Grand Junction CO, 81501 has a requirement to provide water quality sufficient for use by Sterile Processing Services (SPS) for the successful management of critical and semi-critical reusable medical devices (RMD).

2. Objectives Complete all required comprehensive water sample collection and testing that meets the requirements of latest version of the Association for the Advancement of Medical Instrumentation (AAMI) ST108 Water for the Processing of Medical Devices and the Veteran’s Health Administration (VHA) Directive 1116 Management of Critical and Semi-Critical Reusable Medical Devices.

3. Scope of Work The Contractor shall provide all labor, supervision, materials, tools, equipment and industry expertise necessary to complete the service requirements listed in Section 4 – Mandatory Tasks and Deliverables.

4. Mandatory Tasks and Deliverables

4.1. CLIN 0001: Complete a monthly comprehensive water sample collection and testing

4.1.1. Deliverables for CLIN 1001

4.1.1.1. The Contractor shall provide personnel and materials to collect and test water samples for all monthly test locations identified in Attachment A.

4.1.1.2. Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened, and the water allowed to run for at least 60 seconds before a sample is aseptically collected in a sterile, endotoxin-free container. The collection container should not be made of polypropylene, because polypropylene has been shown to inhibit endotoxin detection [78].

4.1.1.3. The Contractor shall report any deficiencies identified during the service work to the Contracting Office Representative (COR) prior to leaving the station at the end of each day.

4.1.1.4. Within 5 business days following the collection of water samples, the Contractor shall provide the COR an electronic report of the test results for each of the testing locations. Each parameter that is tested shall show the actual result compared to the acceptable range permitted by the latest version of AAMI ST108. The actual reading shall be flagged if it falls outside the acceptable range.

4.2. CLIN 0002: Complete a quarterly comprehensive water sample collection and testing.

4.2.1. Deliverables for CLIN 1002

4.2.1.1. The contractor shall provide personnel and materials to collect and test water samples for all quarterly test locations identified on Attachment A.

4.2.1.2. The Contractor shall use appropriate sample containers IAW AAMI ST108 that ensure accurate testing results.

4.2.1.3. The contractor shall report all deficiencies identified during the service work to the COR prior to leaving the station by the end of each day.

4.2.1.4. The Contractor shall provide the COR an electronic report of the laboratory results for each of the testing locations. Each parameter that is tested shall show the actual result compared to the acceptable range permitted by the latest version of AAMI ST108. The actual reading shall be flagged if it falls outside the acceptable range.

4.3. CLIN 0003: Annual Critical Water test for Ionic Characteristics

4.3.1. Deliverables for CLIN 0003

4.3.1.1. The Contractor shall provide personnel and materials to collect and test water samples for all annual testing locations identified on Attachment A.

4.3.1.2. The Contractor shall use appropriate sample containers that ensure accurate test results.

4.3.1.3. The Contractor shall report any deficiencies identified during service work to the COR prior to leaving the station at the end of each day.

4.3.1.4. Within 5 business days following the collection of water samples, the Contractor shall provide the COR an electronic report of the test results for each of the testing locations. Each parameter that is tested shall show the actual result compared to the acceptable range permitted by the latest version of AAMI ST108. The actual reading shall be flagged if it falls outside the acceptable range.

4.4. CLIN 0004: Non-Routine Comprehensive Water Testing

4.4.1. Deliverables for CLIN 0003

4.4.1.1. In the event of a failed test, infrastructure modifications, or concerns by the SPS Chief the contractor shall use this line for invoicing the costs for non-routine or re-testing.

4.4.1.2. The Contractor shall provide personnel and material to collect and test water samples to retest locations that were outside of the acceptable range.

4.4.1.3. The Contractor shall use appropriate sample containers that ensures accurate testing results.

4.4.1.4. The Contractor shall report any deficiency identified during service work to the COR prior to leave the station at the end of each workday.

4.4.1.5. Within 5 business days after the collection of water samples, the Contractor shall provide the COR an electronic report of the laboratory test results for each of the testing locations. Each water chemistry parameter that was tested shall show the actual reading compared to the acceptable range permitted by AAMI ST108.The actual reading shall be flagged on the report if it falls outside the acceptable range.

5. Period of Performance The period of performance shall be from the date of award for a base year and 4 option years. The contractor shall coordinate with the COR to schedule the services outlined in Section 4. Services in this SOW shall be completed during normal hours of operation, which are Monday through Friday, 7:30am-5:00pm, except Federal holidays. Work is to be conducted in a manner which would present the least amount of disruption to the healthcare facility.

The monthly tasks shall be completed on the 15th of each month +/- 7 calendar days.

The quarterly tasks shall be completed every 90 days +/- 7 calendar days.

There are eleven (11) Federal holidays set by law (U.S.C. Title 5 Section 6103). Additional days which are deemed federal holidays by the Government during this contract period shall also be observed.

Under current definitions, five are set by date:

If any of the above falls on a Saturday, then the Friday before shall be observed as a holiday. Similarly, if one falls on a Sunday, then Monday after shall be observed as a holiday.

The other six are set by a day of the week and month:

6. Place of Performance The service work shall take place at:

WCHCS - VA Medical Center 2121 North Avenue (Main Hospital) Grand Junction, CO. 81501

7. Key Personnel Certain skilled experience professionals and/or technical personnel are essential for accomplishing the work to be performed. These individuals are defined as “Key personnel”.

7.1. Domain Knowledge

7.1.1. The Contractor and key personnel shall conform to the latest versions of the Occupational, Safety and Health Act (OSHA), Electrical Safety - NFPA, VHA Directives, State, County, and city laws, ordinances, and regulations.

7.2. Contractor Qualifications

7.2.1. The Contractor laboratory shall have an environmental microbiology accreditation by a nationally recognized accrediting body (Environmental Microbiology Laboratory Accreditation Program (EMLAP), National Environmental Laboratory Accreditation Program (NELAP), etc.)

7.2.2. The laboratory shall perform testing in compliance with the latest version of AAMI ST108.

7.2.3. The laboratory shall have experience performing each referenced test a minimum of 50 times annually.

7.2.4. All Testing equipment shall have a current calibration validation. The contractor shall submit 3 years of calibration records to the Contracting Officer (CO) for the test equipment performing each referenced test.

7.2.5. The Contractor’s staff performing testing against this SOW shall be fully trained to the requirements of AAMI ST108 throughout the term of this contract. Upon request from the CO, the contractor shall provide training records for the personnel providing service work.

8. Type of Contract Firm Fixed Price

9. Changes to the SOW Any changes to the SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. The Contractor shall submit a change order request to the CO and only after the request is approved and a contract modification issued can the Contractor incur an expense and then request compensation for parts and labor via submission of an invoice.

10. Contractor and Government Responsibilities

10.1. Contractor Responsibility

10.1.1. Contractor shall furnish personnel, supervision, knowledge, professional expertise, tools, materials, equipment, and quality control to complete the Mandatory Tasks and Deliverables of this SOW.

10.1.2. The items necessary to perform work as required under this contract shall be furnished, maintained, and operated by the contractor and shall be consistent and fully compliant with all applicable OSHA, ASME, NFPA, Federal regulations.

10.1.3. The Contractor and key personnel shall be responsible for the cost of repair or replacement of any damage to the VA Medical Center structure or equipment caused by the Contractor or key personnel.

10.1.4. The contractor shall provide a minimum of 10 business days’ notice prior to the commencement of work.

10.1.5. Key personnel shall sign in, sign out at Building 8, and communicate ongoing changes with the COR while on-station. Contact information shall be provided to the COR.

10.2. Government Responsibilities

10.2.1. The COR shall provide any relevant documentation regarding the work as required under this SOW. Additional documentation may be available at the request of the contractor.

10.2.2. The VA shall provide a facility escort and access to the areas that require the service work.

11. Formal Acceptance or Rejection of Deliverables

11.1. If deficiencies were discovered not covered by this service contract, Contractor shall

12. Quality Standards for Deliverables – Performance Measures

12.1. The Contractor shall schedule service visits with the COR at least 10 business days prior the commencement of work.

12.2. The field service personnel shall sign in and out in the Engineering Office (Building 8).

12.3. The Contractor shall complete and deliver the field service and lab results within the requirements of the SOW.

12.4. If for any reason a deliverable cannot be achieved on-time according to the schedule of the contract, the contractor shall provide a written explanation to the COR within 3 business days of the scheduled service date. The written transmittal shall site reasons for the delay and shall include a timeline of when the work shall be completed.

13. Security – Privacy Requirements

13.1. The Assessment & Authorization requirements do not apply, and a Security Accreditation Package is not required.

Attachment A:

SPS Water Testing Location and Requirements by Location NOTE: Use Figure 1 to locate the individual test locations. Testing locations on Figure 1 are denoted as “TL” followed by a number.

Requires Monthly Testing: TL1, TL2, TL5, TL6, TL7, TL12, TL13.

Requires Quarterly Testing (refers to the Steam column on Table 1): TL3, TL4, TL8, TL9, TL10, TL11.

Testing Location 1 (TL1) Critical Water - Washer 1

· Testing Frequency: Monthly

Testing Location 2 (TL2) Critical Water – Sink

· Testing Frequency: Monthly

· Testing Frequency for Ionic Groups 1 and 2: Annually ****First Critical Water Point-Of-Use on Distribution Loop**** Testing Location 3 (TL3) Utility Water - Sink

· Testing Frequency: Quarterly

· Testing Frequency for Ionic Groups 1 and 2: Annually ****First Utility Water Point-Of-Use on Distribution Loop**** Testing Location 4 (TL4) Utility Water - Sink

· Testing Frequency: Annually

Testing Location 5 (TL5) Critical Water - Ultrasonic Cleaner

· Testing Frequency: Monthly

Testing Location 6 (TL6) Critical Water - Sonic Irrigator Washer Disinfector

· Testing Frequency: Monthly

Testing Location 7 (TL7): Critical Water - Sink

· Testing Frequency: Monthly

Testing Location 8 (TL8): Utility Water - Sink

· Testing Frequency: Annually

Testing Location 9 (TL9): Utility Water - Sink

· Testing Frequency: Annually

Testing Location 10 (TL10) Steam Condensate - Sterilizer

· Testing Frequency: Quarterly

Testing Location 11 (TL11) Steam Condensate - Sterilizer

· Testing Frequency Quarterly Testing Locations 12 (TL12) Critical Water -Washer 2

· Testing Frequency: Monthly

Testing within Room 3667 (Mechanical Room) Testing Location 13 (TL13) Critical Water - Storage Tank

· Testing Frequency: Monthly

· First point after treatment (loop out of storage tank) – for pH, Alkalinity, Conductivity, Hardness, Bacteria, and Endotoxins tests

· Return line to storage tank (loop return to storage tank) – for Bacteria and Endotoxins Table 1 – Categories and Performance Qualification Levels Of Water Quality for Medical Device Processing

Table 2 – Quantities of Each Test Per Year Read each row horizontally. There are Point of Generation (POG) totals and Point of Use (POU) totals identified horizontally for each type of test (water characteristic column). The annual total POG and POU for each type of test is listed in the far-right column. This aligns with the quantities in the Price Cost Schedule.

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